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510(k) Data Aggregation

    K Number
    K001986
    Device Name
    SURGITRON IEC II
    Manufacturer
    Date Cleared
    2000-09-27

    (90 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGITRON IEC II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K001407
    Device Name
    SURGITRON IEC II
    Manufacturer
    Date Cleared
    2000-07-24

    (81 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGITRON IEC II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K001253
    Device Name
    SURGITRON IEC II
    Manufacturer
    Date Cleared
    2000-05-26

    (37 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGITRON IEC II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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